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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023715
Receipt No. R000025838
Scientific Title Relationship of Eyelid Tension to Glaucoma
Date of disclosure of the study information 2016/08/22
Last modified on 2016/08/22

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Basic information
Public title Relationship of Eyelid Tension to Glaucoma
Acronym Relationship of Eyelid Tension to Glaucoma
Scientific Title Relationship of Eyelid Tension to Glaucoma
Scientific Title:Acronym Relationship of Eyelid Tension to Glaucoma
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To report the postoperative results of Trabeculectomy surgery performed at Okayama University Hospital including the effect of intraocular pressure(IOP) drops and the frequency of complications. And to evaluate the influences of eyelid pressure on the results of trabeculectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes *Intraocular Pressure:measured by Goldmann applanation tonometer
Eyelid pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 groupA hyper eyelid pressure
Interventions/Control_2 groupA normal eyelid pressure
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria glaucoma patients
Key exclusion criteria patients with another ocular surgery
In case that the informed consent was not obtained
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naito Tomoko
Organization Okayama University
Division name Ophthalmology
Zip code
Address 2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL 81-86-235-7297
Email opth@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Takako
Organization Okayama University
Division name Ophthalmology
Zip code
Address 2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL 81-86-235-7297
Homepage URL
Email opth@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 22 Day
Last modified on
2016 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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